BACKGROUND: Previous attempts at reporting oronasal fistula development and secondary speech surgery following cleft palate surgery have been limited to single-center case series. This limitation can be overcome by querying large databases created by health care governing bodies or health care alliances. The authors examined the effect of cleft type and demographic variables on the clinical outcomes. METHODS: Data from the Pediatric Health Information System database were queried for patients, aged 6 to 18 months, who had undergone primary palatoplasty between 2004 and 2009. Subsequent repair of an oronasal fistula and/or secondary speech surgery between 2004 and 2015 was identified by procedure codes. Logistic regression models were used to assess the associations between cleft type with oronasal fistula and with secondary speech surgery. RESULTS: Seven thousand three hundred twenty-five patients were identified, and 6.4 percent (n = 468) had a subsequent repair of an oronasal fistula and 18.5 percent (n = 1355) had a secondary speech operation. Adjusted for age, sex, and race, patients with cleft lip and palate have increased odds of oronasal fistula (OR, 5.60; 95 percent CI, 4.44 to 7.07) and secondary speech surgery (OR, 2.32; 95 percent CI, 2.05 to 2.63). CONCLUSIONS: Using a large, multi-institution billing database, the authors were able to estimate the prevalence of oronasal fistula and surgically treated velopharyngeal insufficiency following primary palatoplasty in the United States. In addition, the authors demonstrated that patients with isolated cleft palate develop fewer oronasal fistulas and require less secondary speech surgery than patients with cleft lip and palate. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.
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